Events

Avis De Sécurité sur cobas p 512 pre-analytical system (64x) and cobas p 612 pre-analytical system (63x)

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Roche Diagnostics.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Roche diagnostics received complaints from two customers that un-spun samples were incorrectly identified as “spun” by the spin status detection on cobas p 512 (64x) pre-analytical system. when non-centrifuged samples incorrectly identified as “spun” are further analyzed, erroneous results may occur and relevant medical risk cannot be entirely excluded. this case made us aware that we need to provide a better specification on the intended use of the spin status detection. the cobas p 512 (64x) and the cobas p 612 (63x) systems are not designed to make a sorting decision based on the spin status detection functionality. while investigating these complaints, we identified that all documentation related to .

Device

cobas p 512 pre-analytical system (64x) and cobas p 612 pre-analytical system (63x)
  • Modèle / numéro de série
    All cobas p 512 (64x) pre-analytical system All cobas p 612 (63x) pre-analytical system
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics